Spinal pain management system and method

ABSTRACT

A method for anesthetizing a human patient undergoing surgery and/or pain block procedure, the method comprising sterilizing the patient&#39;s skin including a target region, the target region including a surgical site including the patient&#39;s spine; inserting at least one cryo-needle into a first tissue region, the cryo-needle having a distal end configured to cool surrounding patient tissue, the first tissue region comprising soft tissue superficial to the one or more vertebra and on a first lateral side of the patients spine; cooling the distal end of the cryo-needle to cause cooling of surrounding patient tissue thus inhibiting one or more sensory nerves in the surrounding patient tissue; thereafter, performing spinal surgery on the patient&#39;s spine at the surgical site; and, thereafter, performing an erector spinae plane block to further inhibit nerves post-operatively in the target region.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/737,956, filed Sep. 28, 2018, and U.S. Provisional Application No.62/745,723, filed Oct. 15, 2018, both of which are hereby incorporatedby reference.

BACKGROUND

The present invention relates to pain reduction associated with spinalnerves for the human body.

Surgery can involve any area of the body. Anterior, lateral, andposterior areas of the body receive innervation from the spinal cord.This invention relates to targeted blockade of nerve impulsesimmediately after leaving the spinal canal. Potential target areasinclude cervical, thoracic, lumbar, and sacral spine. Etiology forsurgery can include congenital, idiopathic, traumatic, or more commonare related to wear and tear from aging. Patients are typicallydischarged with opiates, thus creating a potential cycle for chronicopiate consumption. The present invention relates to pain controlalternatives for blocking nerves exiting the spine and may be analternative which will reduce opiate consumption after routine andcomplex surgery. The invention may allow some patients to avoid surgery.

SUMMARY

The claims, and only the claims, recite the invention. In summary, itmay include methods for treating a patient, more particularly methodsfor anesthetizing a human patient undergoing anterior, posterior,lateral, and/or spinal surgery and/or pain block procedures. The methodcomprising: sterilizing the patient's skin including a target region,the target region including a surgical site including the patient'sspine; inserting at least one cryo-needle into a first tissue region,the cryo-needle having a distal end configured to cool surroundingpatient tissue, the first tissue region comprising soft tissuesuperficial to the one or more vertebra and on a first lateral side ofthe patients spine; cooling the distal end of the cryo-needle to causecooling of surrounding patient tissue thus inhibiting one or moresensory nerves in the surrounding patient tissue; thereafter, performingspinal surgery on the patient's spine at the surgical site; and,thereafter, performing an erector spinae plane block to further inhibitnerves post-operatively in the target region. In some forms the spinalsurgery comprises at least one of: a spinal fusion, a discectomy, alaminectomy, and/or a pain block. In certain embodiments, the one ormore inhibited nerves includes nerves of the dorsal ramus. In some formsthe surgery comprises one or more anterior, posterior, and/or lateralbody procedures which are innervated by spinal nerves, for example oneor more spinal nerves extending from C5 to the sacral nerves.

In certain embodiments, the erector spinae plane block is performed witha local anesthesia. In some forms the local anesthesia is deliveredusing an imageable needle.

In certain embodiments the erector spinae plane block is performed usingan elongate cryo-needle. In some forms the elongate cryoneedle isimageable.

In certain embodiments the cryo-needle comprises two or more needle endsconfigured to cool surrounding patient tissue. In some forms the two ormore needle ends are configured in a generally linear array.

In certain embodiments the method further comprises inserting at leastone cryo-needle into a second patient tissue region, the cryo-needlehaving a distal end configured to cool surrounding patient tissue, thesecond patient tissue region comprising soft tissue superficial to theone or more vertebra and on a second lateral side of the patients spineopposing said first tissue region.

In certain embodiments the inserting and cooling steps are repeatedalong a portion of the patients spinal column. In some forms theinserting and cooling steps are repeated in such a way so thatprogressing in a cranial or caudal direction each subsequent targetregion is laterally offset from the prior target region.

In certain embodiments the present disclosure provides a method foranesthetizing a patient, the method comprising: inserting at least onecryo-needle into a first tissue region, the cryo-needle having a distalend configured to cool surrounding patient tissue, the first tissueregion comprising soft tissue superficial to one or more vertebra and ona first lateral side of the patients spine; cooling the distal end ofthe cryo-needle to cause cooling of surrounding patient tissue at thefirst tissue region thus inhibiting one or more sensory nerves in thesurrounding tissue; inserting at least one cryo-needle into a secondtissue region, the cryo-needle having a distal end configured to coolsurrounding patient tissue, the second tissue region comprising softtissue superficial to one or more vertebra and on the first lateral sideof the patient's spine; and cooling the distal end of the cryo-needle tocause cooling of surrounding patient tissue at the second tissue regionthus inhibiting one or more sensory nerves in the surrounding tissue.

In certain embodiments the above method also comprises inserting atleast one cryo-needle into a third tissue region, the cryo-needle havinga distal end configured to cool surrounding patient tissue, the thirdtissue region comprising soft tissue superficial to one or more vertebraand on the first lateral side of the patient's spine; and cooling thedistal end of the cryo-needle to cause cooling of surrounding patienttissue at the third tissue region thus inhibiting one or more nerves inthe surrounding tissue.

In certain embodiments the cryo-needle comprises two or more needle endsconfigured to cool surrounding patient tissue. In some forms the two ormore needle ends are configured in a generally linear array.

In certain embodiments the inserting and cooling steps are repeatedalong a portion of the patient's spinal column. In some forms theinserting and cooling steps are repeated in such a way so thatprogressing in a cranial or caudal direction each subsequent tissueregion is laterally offset from the prior target region.

In certain embodiments the inserting and cooling steps are repeated onthe second lateral side of the patient's spine.

In certain embodiments the method further comprising performing a painblock or spinal surgery involves spinal nerve distribution from one ormore spinal nerves extending from the cervical spine to sacrum withinnervation of anterior, lateral, and/or posterior of a patient's spine.In some forms the spinal surgery comprises at least one of: a spinalfusion, a discectomy, and/or a laminectomy.

In certain embodiments the one or more inhibited nerves includes nervesof the dorsal ramus.

In certain embodiments, both the erector spinae needle andcryoneurolysis needles may be insulated, thus allowing electricalstimulation and evaluation of motor function.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration showing the posterior cutaneous nerves.

FIG. 2 is a fluoroscopic image of a portion of a patient's spinalcolumn.

FIG. 3 illustrates the distal portion of an example of a cryo-needle foruse with the presently disclosed methods.

FIG. 4 illustrates one embodiment of a method for anesthetizing a humanpatient.

FIG. 5 is a fluoroscopic image showing migration of anesthetic andcontrast agent injected during an erector spinae block procedure.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purpose of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any alterations and further modificationsin the described embodiments, and any further applications of theprinciples of the invention as described herein are contemplated aswould normally occur to one skilled in the art to which the inventionrelates. One embodiment of the invention is shown in great detail;although it will be apparent to those skilled in the relevant art thatsome features that are not relevant to the present invention may not beshown for the sake of clarity.

As used here (claims, specification, and other definitions) thefollowing terms have the following meaning:

Articles and phases such as, “the”, “a”, “an”, “at least one”, and “afirst”, “comprising”, “having” and “including” here are not limited tomean only one, but rather are inclusive and open ended to also include,optionally, two or more of such elements and/or other elements. In termsof the meaning of words or terms or phrases herein, literal differencestherein are not superfluous and have different meaning, and are not tobe synonymous with words or terms or phrases in the same or otherclaims.

The term “means for” in a claim invokes 35 U.S.C. § 112(f), literallyencompassing the recited function and corresponding structure andequivalents thereto. Its absence does not, unless there otherwise isinsufficient structure recited for that claim element. Nothing herein orelsewhere restricts the doctrine of equivalents available to thepatentee.

The term “and/or” is inclusive here, meaning “and” as well as “or”. Forexample, “P and/or Q” encompasses, P, Q, and P with Q; and, such “Pand/or Q” may include other elements as well.

The term “anesthetizing” as used herein has the meaning, a process forproviding temporary loss of sensation, muscle control, and/or awareness.

The term “anterior” as used herein has the meaning, being situatednearest or toward the front of the body. With respect to the spine, theanterior is considered to be the side of the spine closest to thestomach or the throat.

The term “anteriorly” as used herein has the meaning, positioned in alocation more anterior with respect to another object where the anteriorrefers to a position nearer to the front of a reference point.

The term “body portion” as used herein has the meaning, the main orprincipal part of an object. More specifically, it refers to the part ofa vertebra implant that contacts the vertebral body of a neighboringvertebra.

The term “contact” as used herein has the meaning, of two objects thestate or condition of physical touching. As used, contact requires atleast one location where objects are directly or indirectly touching,with or without any other member(s) material in between.

The term “cranial-caudal orientation” as used herein has the meaning, inthe direction along an axis running vertically toward and away from a(standing) patient's skull.

The term “cranial direction” as used herein has the meaning, in thedirection toward the patient's head along the cranial-caudal axis.

The term “caudal direction” as used herein has the meaning, in thedirection towards the patient's feet along the cranial-caudal axis.

The term “cryoanalgesia” (also known as cryoneurolysis) as used hereinhas the meaning is the reversible destruction of the signal carryingparts of a nerve. It is a small subset of treatments under the broadumbrella of cryotherapy.

The term “cryo-needle” as used herein has the meaning, a medical devicehaving a slender, usually sharp pointed body and configured to causefreezing at the distal end, (which may include its tip, but also may beportions near to but proximal to the tip), upon activation.

The term “discectomy” as used herein has the meaning, a surgical removalof all or part of an intervertebral disc.

The term “dorsal ramus” as used herein has the meaning, the posteriordivision of a spinal nerve that forms the dorsal root of the nerve as itemerges from the spinal cord.

The term “Erector Spinae Plane Block” as used herein has the meaning, aparaspinal fascial plane block that involves injection of localanesthetic between the erector spinae muscle and the transverse process,thus blocking inhibiting the dorsal and/or ventral rami of the spinalnerve. Upon injection the local anesthetic spreads in a cranial and/orcaudal direction inhibiting the dorsal and or ventral rami ofneighboring spinal nerves along the spinal cord.

The term “facilitate” as used herein has the meaning, to aid or helpaccomplish an action or a process to make that action or process easier.The act of facilitation does not need to accomplish the action orprocess entirely on its own.

The term “front surface” as used herein has the meaning, an exteriorsurface which may or may not be the anterior most surface.

The term “hole” as used herein has the meaning, a hollow opening withina body, structure, or an object. It can be any shape.

The term “imageable” as used herein has the meaning, a device which isconfigured to allow for medical imaging of the device during use such asby computed tomography (CT), magnetic resonance (MRI), positron emissiontomography (PET), fluoroscopy, and/or ultrasonography. As used hereinthe “imageable” device is configured to allow a user to visualize all ora portion of the device within the patient during a procedure.

The term “laminectomy” as used herein has the meaning, a surgicaloperation to remove the back of one or more vertebrae, usually to giveaccess to the spinal cord or to relieve pressure on nerves.

The term “pain block” as used herein has the meaning, inhibition of oneor more sensory nerves that relay pain signals to a target region of thepatient's body.

The term “local anesthesia” as used herein has the meaning, a medicationthat causes reversible absence of pain sensation in a target area of thebody. When it is used on specific nerve pathways, paralysis also can beachieved.

The term “sensory nerve” as used herein has the meaning, a nerve thatcarries sensory information toward the central nervous system (CNS).

The term “side” as used herein has the meaning, one of the faces on thesurface of an object. An object can have multiple faces with a varietyof orientations. For example, an object may have a front side, a bottomside, a back side, or a top side.

The term “spinal fusion” as used herein has the meaning, a neurosurgicalor orthopedic surgical technique that joins two or more vertebrae. Thisprocedure can be performed at any level in the spine and prevents anymovement between the fused vertebrae. Spinal fusion may also be calledspondylodesis or spondylosyndesis.

The term “spinal surgery” as used herein has the meaning, any surgicalprocedure including the patient's spinal cord.

The term “superficial” as used herein has the meaning, a directionalterm that indicated one structure is located more externally thananother, or closer to the surface of the body.

The term “transverse” as used herein has the meaning, situated orextending across an object or an axis.

The term “vertebra” as used herein has the meaning, a bone or objectthat forms part of the spinal column. The vertebra could be composed ofbone or it can be an implant formed from any variety of materials thatwould be useful to replace bone such as titanium, stainless steel, orother metallic or non-metallic compounds.

The term “withdrawal” as used herein has the meaning, the action ofremoving or taking away something for a particular location.

Until now, traditional cryotherapy treatments were invasive, and usedlarge complicated machines. A new generation of cryo-needles hasrevolutionized the delivery of cryoanalgesia. One example is the ioverasystem by Myoscience.

With cryo-needle systems, doctors are able to deliver precise,controlled doses of cold temperature only to the targeted nerve througha handheld device. This needle-based procedure is safe, and does notdamage or destroy the surrounding tissue.

These cryo-needle based treatments use the body's natural response tocold to treat peripheral nerves and immediately reduce pain—without theuse of drugs. Treated nerves are temporarily stopped from sending painsignals for a period of time, followed by a restoration of function.

It is important to note that cryo-needle therapy, such as the ioveraotherapy, does not treat the underlying cause of the pain. Timelyremediation is necessary to address and treat the cause of pain.

Cryo-needle therapies, such as the iovera treatment, work by applyingtargeted cold to a peripheral nerve. A precise cold zone is formed underthe skin—cold enough to immediately prevent the nerve from sending painsignals without causing damage to surrounding structures. The effect onthe nerve is temporary, providing pain relief until the nerveregenerates and function is restored.

Cryo-needle therapies, such as the ioverao treatment, generally do notinclude injection of any substance—drugs, opioids or narcotics. Theeffect of this treatment is immediate and can last weeks to severalmonths depending on the multiple factors, including the patients anatomyand pain tolerance. In one study, majority of the patients sufferingfrom osteoarthritis of the knee have experienced pain and symptom reliefbeyond 150 days.” See also, Radnovich, R. et al. “Cryoneurolysis totreat the pain and symptoms of knee osteoarthritis: a mulitcenter,randomized, double-blind, sham-controlled trial.” Osteoarthritis andCartilage (2017) p1-10. (incorporated herein by reference) Cryo-needletherapies, such as the lovera technology, use FDA approved devices thathave needles with ends that create ice balls, allowing targeted nervesto be stunned, and completely reversible weeks to months later. Thistechnology has allowed tremendous pain control for orthopedic proceduressuch as total knee and total hip replacement. Freezing the sensory skinnerves of the anterior thigh for total knee replacement and the lateralthigh for hip replacement has resulted in significant drops in opioidneed and postoperative pain scores. Similar results are available forsensory freezing the posterior cutaneous nerves of the spine. Freezingcutaneous nerves alone may not provide sufficient pain relief. We havesupplemented the cryoanalgesia treatment with a nerve block called anErector Spinae Block. Erector spinae blocks are generally placed byphysicians, for example anesthesiologists, using ultrasound. Erectorspinae blocks may also be placed by surgeons using guided navigationsurgery software. Using cryo-needle technology for previously untriedlumbar fusion spine procedures provides surprising success. Otherpossible applications include anesthesia pain blocks for chronic pain,thus avoiding more invasive epidural steroid injections. Routine lumbardiscectomy and laminectomy patients could receive cryo-needle treatmentat the end of surgeries. More complex cervical and thoracic spineapplications may also be possible.

Sensory nerves that are targeted for pain relief may innervate anterior,posterior, and/or lateral parts of the body. In certain embodiments thecurrent disclosure provides methods of anesthetizing a patientundergoing surgical procedures at or in anterior, posterior, and/orlateral parts of the body.

The lateral region of the body includes lateral portions of the thoraxas well as extremities, hips, knees, arms, elbows, shoulders, hands,feet, and legs.

The anterior region of the body which may be anesthetized using theprovided methods includes for example: skin, muscle, nerves, bones,chest wall, breast, esophagus, trachea, lungs, pleura, diaphragm,mediastinum, heart, pericardium, great vessels with and without pumpoxygenator, anterior cervical spine, anterior thoracic spine, anteriorlumbar spine, upper anterior abdominal wall including hernias (lumbar,ventral, umbilical, incisional, diaphragmatic, omphalocele), anteriormajor abdominal blood vessels, spleen, liver, pancreas, liver, anteriorlower abdomen wall (hernias), kidney uterus, bladder, adrenal glands,prostate, vagina, and/or anterior pelvis. Surgical procedures which maybe performed in conjunction with the anterior region of the body inaccordance with the present disclosure include, for example:thoracoscopy, thoracotomy, transplant, anterior intraperitonealprocedures such as spleen, liver, pancreas, liver transplant, and/orgastric bypass, abdominoperineal resection, hysterectomy, pelvicexenteration, nephrectomy, adrenalectomy, renal transplant,prostatectomy, and/or vaginal procedures.

The posterior region of the body which may be anesthetized using theprovided methods includes, for example: cervical spine, thoracic spine,lumbar spine sacral spine, extensive complex spine and spinal cordinstrumentation cervical spine to sacral spine

FIG. 1 is an illustration showing the posterior cutaneous nerves. Incertain aspects a target region 100 may be identified forcryoneurolysis. For example in the illustrated embodiment the targetregion 100 spans a generally linear region lateral to midline 102 andextending along the spinal column from L2 to S2. The illustrated targetregion extends generally from L2 to S3. It is to be understood that atarget region for use with any embodiment disclosed herein can extendover, and thus target nerves emerging from, any number of vertebralsegments including C1 through C7, T1 through T12, L1 through L3, as wellas the sacrum and coccyx. It is also within the scope of the disclosurethat multiple target regions may be treated in a single procedure.

FIG. 2 is a fluoroscopic image of a portion of a patient's spinalcolumn. In the illustrated embodiment the patient is being prepped forL4-L5 lumbar fusion. In the illustrated embodiment the top of L4 andbottom of L5 vertebral bodies are identified, the transverse process ofL4 and L5 are identified, a first target region 100 is drawn at the middistance width of the transverse process. In the illustrated embodimenta second target region 104 is identified opposing the first targetregion 100. Cryoneurolysis is done along the target regions 100 and/or104 from the top of L4 to the bottom of L5, transverse process middistance from the vertebral body.

FIG. 3 illustrates the distal portion of one embodiment of a cryo-needlefor use with the presently disclosed methods. Briefly, cryo-needle 200comprises body wall 210 having outer surface 212 and inner surface 214,inner surface 214 defining inner lumen 216 defining a first fluid flowpath 240. Needle end 202 is positioned near the distal most portion ofthe needle. Cannula 220 is disposed within inner lumen 216. Cannula 220comprises cannula wall 222 having an outer cannula surface 224 and innercannula surface 226. Inner cannula surface 226 defining a second fluidflow path 242. In the illustrated embodiment a cooling fluid and/or gastravels distally through the first fluid flow path to the needle end.The cooling fluid and/or gas causes an ice ball 250 to form at theneedle end, and returns through the second fluid flow path 242. Incertain embodiments needle end 202 may include a Joule-Thomson annulus250.

FIG. 4 depicts one embodiment of a method of anesthetizing a patient asdisclosed herein. In the illustrated embodiment a user 400, for examplea physician positions a cryo-needle device 402, having one or morecryo-needle ends as discussed herein positioned at or near a distalportion 404 of the cryo-needle device, at a first target region 406 onpatient 410. In the illustrated embodiment the first target regionopposes a second target region 408 over midline 412. Midline 412 issuperficial to the patients' spine such that target regions 406 and 408are both lateral to the midline along the patients' spine. In certainembodiments a target region comprises soft tissue superficial to one ormore target spinal nerves. Thus in certain embodiments a target regionis selected to target underlying spinal nerves. In the illustratedembodiment one or more cryo-needle ends are inserted into the firsttarget region. In accordance with the present disclosure the needle endsare cooled to cause cooling of surrounding patient tissue, thusinhibiting one or more of the target spinal nerves in the surroundingtissue. In certain embodiments, multiple insertion and cooling cyclesare performed within a given target region. In accordance with someforms of practicing the disclosed method, a second target regionopposing the first target region may also be treated in a similarfashion, thus bilaterally anesthetizing a region of the patients' spine.

FIG. 5 is a fluoroscopic image of a portion of a patient's spinal column504. In the illustrated embodiment, migration of anesthetic and contrastagent 502 injected during an erector spinae block procedure is evident.The image clearly shows anesthetic migrated in both a cranial and caudaldirection from the locus of injection 500, allowing for analgesic effecton spinal nerves pass through the affected area.

In certain embodiments the present disclosure provides a method foranesthetizing a human patient undergoing surgery, and/or pain blockprocedures, the method comprising: sterilizing the patient's skinincluding a target region, the target region including a surgical siteincluding the patient's spine; inserting at least one cryo-needle into afirst tissue region, the cryo-needle having a distal end configured tocool surrounding patient tissue, the first tissue region comprising softtissue superficial to the one or more vertebra and on a first lateralside of the patients spine; cooling the distal end of the cryo-needle tocause cooling of surrounding patient tissue thus inhibiting one or moresensory nerves in the surrounding patient tissue; thereafter, performingspinal surgery on the patient's spine at the surgical site; and,thereafter, performing an erector spinae plane block to further inhibitnerves post-operatively in the target region.

In some forms the surgery comprises one or more of an anterior,posterior, lateral, and/or spinal surgery, wherein the area surgicallytreated is innervated by a spinal nerve. In some forms the spinalsurgery comprises at least one of: a spinal fusion, a discectomy, alaminectomy, and/or a pain block. In certain embodiments, the one ormore inhibited nerves includes nerves of the dorsal ramus.

In certain embodiments, both the erector spinae needle andcryoneurolysis needles may be insulated, thus allowing electricalstimulation and evaluation of motor function.

In certain embodiments, the erector spinae plane block is performed witha local anesthesia. In some forms the local anesthesia is deliveredusing an imageable needle.

In certain embodiments the erector spinae plane block is performed usingan elongate cryo-needle. In some forms the elongate cryo-needle isimageable.

In accordance some forms of practicing the disclosed methods, animageable cryo-needle is used, such that the erector spinae block and/orthe cryo-needle are placed using guidance from a medical imaging device.

In certain embodiments the cryo-needle comprises two or more needle endsconfigured to cool surrounding patient tissue. In some forms the two ormore needle ends are configured in a generally linear array.

In certain embodiments the above method further comprises inserting atleast one cryo-needle into a second patient tissue region, thecryo-needle having a distal end configured to cool surrounding patienttissue, the second patient tissue region comprising soft tissuesuperficial to the one or more vertebra and on a second lateral side ofthe patients spine opposing said first tissue region.

In certain embodiments the inserting and cooling steps are repeatedalong a portion of the patients spinal column. In some forms theinserting and cooling steps are repeated in such a way so thatprogressing in a cranial or caudal direction each subsequent targetregion is laterally offset from the prior target region.

In certain embodiments the present disclosure provides a method foranesthetizing a patient, the method comprising: inserting at least onecryo-needle into a first tissue region, the cryo-needle having a distalend configured to cool surrounding patient tissue, the first tissueregion comprising soft tissue superficial to one or more vertebra and ona first lateral side of the patients spine; cooling the distal end ofthe cryo-needle to cause cooling of surrounding patient tissue at thefirst tissue region thus inhibiting one or more sensory nerves in thesurrounding tissue; inserting at least one cryo-needle into a secondtissue region, the cryo-needle having a distal end configured to coolsurrounding patient tissue, the second tissue region comprising softtissue superficial to one or more vertebra and on the first lateral sideof the patient's spine; and cooling the distal end of the cryo-needle tocause cooling of surrounding patient tissue at the second tissue regionthus inhibiting one or more sensory nerves in the surrounding tissue.

In certain embodiments the above method also comprises inserting atleast one cryo-needle into a third tissue region, the cryo-needle havinga distal end configured to cool surrounding patient tissue, the thirdtissue region comprising soft tissue superficial to one or more vertebraand on the first lateral side of the patient's spine; and cooling thedistal end of the cryo-needle to cause cooling of surrounding patienttissue at the third tissue region thus inhibiting one or more nerves inthe surrounding tissue.

In certain embodiments the cryo-needle comprises two or more needle endsconfigured to cool surrounding patient tissue. In some forms the two ormore needle ends are configured in a generally linear array.

In certain embodiments the inserting and cooling steps are repeatedalong a portion of the patient's spinal column. In some forms theinserting and cooling steps are repeated in such a way so thatprogressing in a cranial or caudal direction each subsequent tissueregion is laterally offset from the prior target region.

In certain embodiments the inserting and cooling steps are repeated onthe second lateral side of the patient's spine.

In certain embodiments the method further comprising performing spinalsurgery on the patient's spine. In some forms the spinal surgerycomprises at least one of: a spinal fusion, a discectomy, and/or alaminectomy.

In certain embodiments the one or more inhibited nerves includes nervesof the dorsal ramus.

Alternatively, or in combination with the above guided surgicalnavigation software has developed and evolved over the past two decades.For example, the Stealth surgical navigation system by Medtronic. Today,surgeons (e.g. neurosurgeon or orthopedic spine surgeon) rely on propersoftware for complex spine procedures. Evolution of surgical practicelead to innovations like CT/MRI guided fusions, passive markers, touchscreen displays and laser surface registration. Postoperative multimodalpain pathways have been marginal at best for controlling severe painassociated with these complex spine procedures. Regional anesthesia painblocks have not been commonly practiced with spine surgery for multiplereasons. For example, guided navigation requires sensory monitoring ofspinal cord signals throughout the procedure. Local anesthetics would,or may, prevent or impede sensory monitoring. Thus, preoperative painblocks using conventional local anesthetics before surgery is notnormally possible. In addition, reducing postoperative pain with localanesthetic pain blocks may mask inadvertent surgical epidural hematoma.

The current inventor has confirmed the efficacy of effective paincontrol allowing same day ambulation after complex spine fusion usingErector Spinae Plane Block (ESPB) in combination with cryoanalgesia.After cryo-needle treatment along a target region of the spine, ESPBcatheters were placed by ultrasound above the anticipated surgical sitebefore surgery. The catheters were dosed with local anesthetic at theend of surgery.

Placing ESPB catheters may be difficult and reproducibility requiresexperienced anesthesia. We have performed surgeon intraoperative singleinjection ESPB in the surgical field using generic regional anesthesiablock needles. The ESPB block was aided using guided navigation softwareand a guided pointer to safely facilitate placement on the transverseprocess for appropriate block. The following is needed for repeatable,safe, precision placement for intraoperative surgeon placed ESPB:

1. A guided navigation surgery software compatible block needle withattached tubing for surgeon intraoperative direct placement of localanesthetic for an ESPB. Guided navigation technology in an actual blockneedle will easily allow precise depth and location placement.

2. Some may elect not to use a “guided navigation surgery softwarecompatible block needle” to perform an ESPB. Alternatively, a guidednavigation surgery software compatible sheath or similar device wouldallow guided entry for the following: regional anesthesia block needleto be used through the guided navigation software compatible sheathdevice for ESPB, and/or any available cryoneurolysis needle to be placedthrough the sheath device precisely into a surgical site.

3. A guided navigation surgery software compatible cryoneurolysisneedle. Current cryoneurolysis needle techniques use anatomic landmarks,ultrasound, or fluoroscopy for guidance to target areas. A guidednavigation surgery software compatible cryoneurolysis needle would notrequire a navigation sheath for skin entry and could be used directly ontarget surgical area.

4. Use of a non-guided navigation surgery software compatible ESPBneedle with tubing, identical to the guided navigation surgery softwarecompatible ESPB needle, to allow a surgeon to perform an intraoperativesingle injection ESPB guided by fluoroscopy, for routine spineprocedures. Physicians are comfortable with similar designs.

The invention may include any one or more articles or devices made byany of the claimed methods and/or may by different methods but with aclaimed composition.

The language used in the claims and the written description and in theabove definitions is to only have its plain and ordinary meaning, exceptfor terms explicitly defined above. Such plain and ordinary meaning isdefined here as inclusive of all consistent dictionary definitions fromthe most recently published (on the filing date of this document)general purpose Webster's dictionaries and Random House dictionaries.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges, equivalents, and modifications that come within the spirit ofthe inventions defined by following claims are desired to be protected.All publications, patents, and patent applications cited in thisspecification are herein incorporated by reference as if each individualpublication, patent, or patent application were specifically andindividually indicated to be incorporated by reference and set forth inits entirety herein.

1. A method for anesthetizing a human patient undergoing surgery andsurgery pain block procedures, the method comprising the acts of:sterilizing the patient's skin including a target region, the targetregion including a site including a portion of the patient's spineassociated with one or more target spinal nerves which innervate asurgical site for the surgery; inserting at least one cryo-needle into afirst tissue region, the cryo-needle having a distal end configured tocool surrounding patient tissue, the first tissue region comprising softtissue superficial to the target spinal nerves and on a first lateralside of the patients spine; cooling the distal end of the cryo-needle tocause cooling of surrounding patient tissue thus inhibiting one or moreof the target spinal nerves in the surrounding patient tissue;thereafter, performing surgery on the patient at the surgical site; and,thereafter, performing an erector spinae plane block to further inhibitnerves post-operatively in the target region.
 2. The method of claim 1,wherein the surgery comprises one or more of an anterior, posterior,lateral, and/or spinal surgery.
 3. The method of claim 2, wherein thespinal surgery comprises at least one of: a spinal fusion, a discectomy,a laminectomy.
 4. The method of claim 1, wherein the one or moreinhibited nerves includes nerves of the dorsal ramus.
 5. The method ofclaim 1, wherein the erector spinae plane block is performed with alocal anesthesia.
 6. The method of claim 5, wherein the local anesthesiais delivered using an imeagable needle.
 7. The method of claim 5,wherein the erector spinae plane block is performed using an elongatecryo-needle.
 8. The method of claim 7, wherein the elongate cryoneedleis imageable.
 9. The method of claim 5, wherein the cryo-needlecomprises two or more needle ends configured to cool surrounding patienttissue.
 10. The method of claim 9, wherein the two or more needle endsare configured in a generally linear array.
 11. The method of claim 1,further comprising inserting at least one cryo-needle into a secondpatient tissue region on the same patient, the cryo-needle having adistal end configured to cool surrounding patient tissue, the secondpatient tissue region comprising soft tissue superficial to the one ormore vertebra and on a second lateral side of the patients spineopposing said first tissue region.
 12. The method of claim 11, whereinsaid inserting and said cooling steps are repeated along a portion ofthe patients spinal column.
 13. The method of claim 12, wherein saidinserting and said cooling acts are repeated in such a way so thatprogressing in a cranial or caudal direction each subsequent targetregion is laterally offset from the prior target region.
 14. A methodfor anesthetizing a patient, the method comprising the acts of:inserting at least one cryo-needle into a first tissue region, thecryo-needle having a distal end configured to cool surrounding patienttissue, the first tissue region comprising soft tissue superficial toone or more vertebra and on a first lateral side of the patients spine;cooling the distal end of the cryo-needle to cause cooling ofsurrounding patient tissue at the first tissue region thus inhibitingone or more sensory nerves in the surrounding tissue; inserting at leastone cryo-needle into a second tissue region, the cryo-needle having adistal end configured to cool surrounding patient tissue, the secondtissue region comprising soft tissue superficial to one or more vertebraand on the first lateral side of the patient's spine; and cooling thedistal end of the cryo-needle to cause cooling of surrounding patienttissue at the second tissue region thus inhibiting one or more sensorynerves in the surrounding tissue.
 15. The method of claim 14, furthercomprising: inserting at least one cryo-needle into a third tissueregion, the cryo-needle having a distal end configured to coolsurrounding patient tissue, the third tissue region comprising softtissue superficial to one or more vertebra and on the first lateral sideof the patient's spine; and cooling the distal end of the cryo-needle tocause cooling of surrounding patient tissue at the third tissue regionthus inhibiting one or more nerves in the surrounding tissue.
 16. Themethod of any one of claim 15, wherein the cryo-needle comprises two ormore needle ends configured to cool surrounding patient tissue.
 17. Themethod of claim 16, wherein the two or more needle ends are configuredin a generally linear array.
 18. The method of claim 14, wherein saidinserting and said cooling steps are repeated along a portion of thepatient's spinal column.
 19. The method of claim 18, wherein saidinserting and said cooling acts are repeated so that progressing in acranial or caudal direction each subsequent tissue region is laterallyoffset from the prior target region.
 20. The method of any one of claim14, wherein said inserting and said cooling acts are repeated on thesecond lateral side of the patient's spine.
 21. The method of claim 14,further comprising performing spinal surgery on the patient's spine. 22.The method of claim 21, wherein the spinal surgery comprises at leastone of: a spinal fusion, a discectomy, and/or a laminectomy.
 23. Themethod of claim 14, wherein the one or more inhibited nerves includesnerves of the dorsal ramus.